Effect of Exercise Training in Arterial and Chronic Thromboembolic Pulmonary Hypertension in Switzerland and Standardization With European Countries
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 6 Minute walking test
研究概览
简要总结
Pulmonary Hypertension (PH) is a serious disease with a dismal prognosis when left untreated. Advances in medical therapy have improved survival according to recent registries and systematic reviews, but are associated with high healthcare costs.
Earlier studies in Heidelberg, Germany showed good evidence for the effect of exercise training on improving exercise performance, quality of life and pulmonary hemodynamics in patients with pulmonary hypertension.
The main objectives of the present project are:
- to investigate the quality of the implementation of a standardized 3 week in-hospital exercise training program on markers of outcome and disease severity in PH-patients in Switzerland immediately after training and after 3 and 12 month.
- to look whether training with hyperoxia vs. standard care might be more effective.
This is a multicentre, randomized parallel-group trial where the intervention rehabilitation is delayed in one group so that they can serve as standard care controls for the others.
In a nested single-centre randomized-controlled trial patent will additionally be randomized to receive either usual rehabilitation (UR) or rehabilitation with standardized supplemental oxygen therapy (SSOT) during nights and ergometer training.
Patients will receive a PH specific rehabilitation program during 3 weeks followed by an instructed home-based training program for 12 weeks. Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights upon written informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •WHO functional class II-IV
- •PH diagnosed by right heart catheter showing:
- •Baseline mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg
- •Baseline pulmonary vascular resistance (PVR) > 240 dyn x s x cm-5
- •Baseline pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg
- •Patients receiving maximal PH therapy including intensified treatment with diuretics and who have been stable for 2 months before entering the study
- •PH target therapy should not be expected to change during the entire 15-week study period
- •Negative pregnancy test (β-HCG) at the start of the trial
- •Able to understand and willing to sign the Informed Consent Form
排除标准
- •PH due to significant left heart disease (Wedge ≥ 15mmHg) or lung disease (FEV1 ≤ 60% predicted)
- •Pregnancy at study onset
- •Walking disability
- •Any change in disease-targeted therapy within the last 2 months
- •Any subject who is scheduled to receive another investigational drug during the course of this study
- •Any other relevant concomitant disease
- •Systolic blood pressure < 85 mmHg
- •History or suspicion of inability to cooperate adequately
研究组 & 干预措施
Immediate Rehabilitation
The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
干预措施: respiratory and exercise therapy (Behavioral)
Immediate Rehabilitation with oxygen
The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights.
干预措施: respiratory and exercise therapy with supplemental oxygen (Behavioral)
Delayed Rehabilitation
Waiting group that participates in the rehabilitation program after 3 months. The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
干预措施: respiratory and exercise therapy (Behavioral)
Delayed Rehabilitation with oxygen
Waiting group that participates in the rehabilitation program after 3 months. The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights.
干预措施: respiratory and exercise therapy with supplemental oxygen (Behavioral)
结局指标
主要结局
6 Minute walking test
时间窗: Change from Baseline to 15 weeks
Constant cardiopulmonary exercise testing change in endurance time
时间窗: Change from Baseline to 15 weeks
次要结局
- Cognitive function (questionnaire)(Baseline, 3 weeks, 15 weeks, 6 and 12 months)
- Quality of Life (questionnaire)(Baseline, 3 weeks, 15 weeks, 6 and 12 months)
- Lung function (physiological parameter)(Baseline, 3 weeks, 15 weeks, 6 and 12 months)
- Sit-to-Stand (physiological parameter)(Baseline, 3 weeks, 15 weeks, 6 and 12 months)
- Stair Ascent (physiological parameter)(Baseline, 3 weeks, 15 weeks, 6 and 12 months)
- Hemodynamic (physiological parameter)(Baseline, 3 weeks, 15 weeks, 6 and 12 months)
- Functional class (scale)(Baseline, 3 weeks, 15 weeks, 6 and 12 months)
- Daily activity (energy expenditure, steps per day, sleep time and efficiency, lying down time, physical activity level, metabolic equivalent units)(Baseline, 3 weeks, 15 weeks, 6 and 12 months)